BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2901489 · Received January 8, 2013

    Report

    Report Number
    3003742446-2013-00010
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    July 26, 2012
    Report Date
    December 12, 2012
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS INCLUDED ATENOLOL, BIVALIRUDIN, PLAVIX, ISOSORBIDE, NORVASC, OMEPRAZOLE, AND VERAPAMIL. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT THIS (B)(4) STUDY PATIENT SUFFERED RESTENOSIS APPROXIMATELY 33 MONTHS POST INDEX PROCEDURE. THIS IS (B)(6) MALE WITH MEDICAL HISTORY INCLUDING HYPERTENSION, HISTORY OF MYOCARDIAL INFARCTION, HISTORY OF PREVIOUS PCI (2006), FAMILY OF HISTORY OF CORONARY ARTERY DISEASE, HISTORY VT ISCHEMIC CARDIOMYOPATHY S/P DUAL CHAMBER ICD, HISTORY OF ESOPHAGEAL REFLUX, HISTORY OF ALLERGY (CODEINE) AND PAST SMOKER. DURING THE INDEX PROCEDURE, THE FIRST LESION WAS IN THE 1OM THAT WAS DESCRIBED AS 28MM IN LENGTH, CLASS C, AND DE NOVO WITH 70% STENOSIS THAT WAS TREATED WITH A 2.75X33MM CYPHER RX. THE SECOND LESION WAS IN THE PROXIMAL CIRCUMFLEX DESCRIBED AS 8MM IN LENGTH, CLASS C, AND DE NOVO WITH 70% STENOSIS THAT WAS TREATED WITH A 3.0X13MM CYPHER STENT. THE LESION WAS SHOWN COMPLEX WITH A FOLLOWING COMMENT "BIFURCATION WITH SIDE BRANCH >= 2.5MM". APPROXIMATELY 33 MONTHS LATER, THE PATIENT EXPERIENCED ANGINA AND UNDERWENT REVASCULARIZATION OF THE 1ST OBTUSE MARGINAL. UPON FOLLOWING-UP WITH THE SITE, IT WAS REPORTED THAT NONE OF THE STUDY STENTS WERE RESTENOSED. BOTH STUDY STENTS WERE NOTED TO BE PATENT. HOWEVER THE LESION WAS ONLY WITHIN 5MM OF 1OM STUDY STENT. THE EVENT RESOLVED WITHOUT SEQUELAE. THE EVENT WAS POSSIBLY RELATED TO THE STUDY STENT, PROCEDURE, AND DRUG. THE EVENT RESOLVED WITHOUT SEQUELAE. THE STUDY STENT REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15018698 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. IN-STENT RESTENOSIS IS A WELL-KNOWN POTENTIAL COMPLICATION FOR THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU. IN THE LITERATURE, IN-STENT STENOSIS RATES RANGE FROM 11% TO 39% FROM 6 TO 12 MONTHS AFTER STENT PLACEMENT. RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. IN-STENT STENOSIS WAS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE INSTENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THERE ARE PATIENT AND LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, SPECIFICALLY THE RISK FACTORS FOR ATHEROSCLEROTIC DISEASE; I.E. HYPERTENSION AND SMOKING.

    Description of Event or Problem · 1

    THE EMAIL RECEIVED FOR (B)(6) INDICATED THAT APPROXIMATELY (B)(6) POST INDEX PROCEDURE, A PATIENT EXPERIENCED ANGINA AND UNDERWENT REVASCULARIZATION OF THE 1ST OBTUSE MARGINAL. DURING THE INDEX PROCEDURE, THE FIRST LESION WAS IN THE 1 OM THAT WAS DESCRIBED AS 28 MM IN LENGTH, CLASS C, AND DE NOVO WITH 70% STENOSIS THAT WAS TREATED WITH A 2.75 X 33 MM CYPHER RX. THE SECOND LESION WAS IN THE PROXIMAL CIRCUMFLEX DESCRIBED AS 8 MM IN LENGTH, CLASS C, AND DE NOVO WITH 70% STENOSIS THAT WAS TREATED WITH A 3.0 X 13 MM CYPHER STENT. THE LESION WAS SHOWN COMPLEX WITH A FOLLOWING COMMENT "BIFURCATION WITH SIDE BRANCH >= 2.5MM". APPROXIMATELY (B)(6) LATER, THE PATIENT EXPERIENCED ANGINA AND UNDERWENT REVASCULARIZATION OF THE 1ST OBTUSE MARGINAL. UPON FOLLOWING-UP WITH THE SITE, IT WAS REPORTED THAT NONE OF THE STUDY STENTS WERE RESTENOSED. BOTH STUDY STENTS WERE NOTED TO BE PATENT. HOWEVER THE LESION WAS WITHIN 5 MM OF 1 OM STUDY STENT. THE EVENT RESOLVED WITHOUT SEQUELAE. THE EVENT WAS POSSIBLY RELATED TO THE STUDY STENT, PROCEDURE, AND DRUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8607 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 15018698

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R